Identification of Gait-related Digital Biomarkers of Bone Health in Spinal Muscular Atrophy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The objective of this study is to understand how spatiotemporal and kinetic gait parameters are associated with bone health in pwSMA who are receiving DMT. We hypothesize that gait parameters are associated with BMD and can determine fracture risk in pwSMA. This is an observational study that involves one in-clinic visit (approximately 3 hours) with remote follow-up visits (approximately 15 minutes) every 3 months for 1 year to collect fracture and medical history. Each of the assessments included in this study are non-interventional and are not intended as a treatment nor are they at the level of standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 50
Healthy Volunteers: f
View:

• Confirmed diagnosis of 5qSMA

• Between 8 and 50 years of age

• Able to walk 10 meters without support or an assistive device

• All participants who meet the inclusion criteria regardless of treatment status will be included, including those on adjuvant therapies, whether investigational or approved

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Cara Kanner, PT, DPT, EdD
chy2112@cumc.columbia.edu
516-581-8150
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 22
Treatments
Spinal Muscular Atrophy
Ambulatory children and adults at least 8 years old by the time of enrollment with genetically confirmed SMA.
Sponsors
Collaborators: Biogen
Leads: Jacqueline Montes

This content was sourced from clinicaltrials.gov